Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Completed
• CT.gov ID: NCT02619552
• Collaborator: Vanderbilt University (Other), Milton S. Hershey Medical Center (Other), Mercy Medical Center (Other)
• Enrollment: 50
• Locations: 4
• Actual Duration (Months): 95
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Crohn's disease is a chronic inflammatory condition of the intestines that causes abdominal pain, diarrhea, tunnels around the anus (fistulas), and extraintestinal symptoms. Effective medical treatments exist to treat the disease; however they can have significant side effects.

Previous studies have shown that sexual function is impaired in patients with Crohn's disease. It is likely that both the symptoms related to the disease, medications used to treat the disease, and surgery all impair sexual function in a variety of ways. For example, body image may be impaired, patients may be worried about bowel incontinence or unpleasant odors associated with diarrhea, patients may have significant pelvic pain secondary to perianal fistulas, or they may have painful intercourse from adjacent inflammation or scarring in the pelvis. The impact of medical treatment on patient's ability to regain sexual function is not known.

The investigators propose a 6 month study to compare sexual function before and after treatment in patients with Crohn's disease about to initiate therapy with an anti-TNF drug for treatment of perianal fistula or intestinal Crohn's or about to initiate therapy with steroids.

The investigators anticipate that the investigators will show that therapy with an anti TNF agent will result in a more rapid and greater return of sexual function than steroids. This information will be important to help counsel patients about the optimal treatment to begin for treatment of their Crohn's disease. Furthermore, it would be the first study to evaluate the impact of medical therapy on sexual function.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease; IBD	Drug: Anti-TNF; Drug: Anti-TNF; Drug: Steroids

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease
• Actual Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Jun 1, 2018
• Actual Study Completion Date: Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Anti-TNF (Remicade, Humira or Cimzia) for luminal CD All participants are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.	Drug: Anti-TNF; All participants in this arm receive an anti-TNF for the treatment of luminal CD. They are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.; Other Names: Remicade, Humira, Cimzia
Anti-TNF (Remicade, Humira or Cimzia)for perianal CD All participants are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.	Drug: Anti-TNF; All participants in this arm receive an anti-TNF for the treatment of perianal CD. They are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.; Other Names: Remicade, Humira, Cimzia
Steroid (Prednisone or budesonide) for luminal CD All participants are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.	Drug: Steroids; All participants in this arm receive steroids for the treatment of luminal CD. They are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.; Other Names: Prednisone, Budesonide

Outcome Measures

Primary Outcome Measures

1. Assessment of Sexual Function [6 months]

   Sexual Function Questionnaire

2. Assessment of Disease Activity [6 months]

   Harvey Bradshaw Index

3. Assessment of Quality of Life [6 months]

   Short Inflammatory Bowel Disease Questionnaire

4. Assessment of Body Image [6 months]

   Body Image Scale

5. Assessment of Depression [6 months]

   PHQ 9

6. Assessment of Perianal Disease Activity [6 months]

   Perianal Disease Activity Index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of Crohn's disease confirmed by standard criteria

• Active luminal Crohn's disease defined by an HBI score of >4 or with draining perianal Crohn's disease a) Active perianal Crohn's disease defined a presence of draining perianal fistula on physical exam19

• Patients with active luminal Crohn's disease must be initiating treatment with an anti-TNF agent (Remicade, Humira, Cimzia, or Simponi) or a steroid (prednisone, Entocort, or Uceris).

• Patients with active perianal disease must be initiating therapy with an anti-TNF agent (Remicade, Humira, Cimzia, or Simponi).

• Can understand written instructions in English

Exclusion Criteria:

• Previous primary non-response to an anti-TNF

• Uncontrolled medical or psychiatric disease (a. Degenerative neurologic condition, b.Unstable angina, c.Class III/IV congestive heart failure, d.Severe asthma or chronic obstructive pulmonary disease, e.Symptomatic peripheral vascular disease, f. Chronic renal insufficiency (creatinine > 2.0), g. Malignancy within the last 3 years (excluding squamous or basal cell cancers of the skin), h. Poorly controlled depression, mania, and schizophrenia, i. Active infection, j. Acquired immunodeficiency syndrome)

• Inability to adhere to the protocol

• Need for imminent surgery other than an exam under anesthesia

• Under 18 years of age.

• Pregnancy

• Use of concurrent prednisone >30 mg per day in the anti-TNF groups

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mercy Medical Center	Baltimore	Maryland	United States	21201
2	University of Maryland School of Medicine	Baltimore	Maryland	United States	21201
3	Penn State Hershey Medical Center	Hershey	Pennsylvania	United States
4	Vanderbilt University	Nashville	Tennessee	United States

Sponsors and Collaborators

• University of Maryland, Baltimore
• Vanderbilt University
• Milton S. Hershey Medical Center
• Mercy Medical Center

Investigators

• Principal Investigator: Raymond Cross, MD, MS, University of Maryland, Baltimore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Raymond Cross, Professor of Medicine, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT02619552
• Other Study ID Numbers: HP-00050472
• First Posted: Dec 2, 2015
• Last Update Posted: Mar 9, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Crohn Disease; Prednisone; Budesonide; Adalimumab; Infliximab; Certolizumab Pegol

Study Results

No Results Posted as of Mar 9, 2022